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Effects of Aerobic Training Post-stroke

13 mai 2019 mis à jour par: Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais

Effects of Aerobic Training on Physical Activity Levels and Sedentary Behavior in Subjects Post-stroke: a Randomized Controlled Trial

Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Therefore, the primary objective will be to investigate the effects of aerobic treadmill training on physical activity levels and sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation.

A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve), or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4 participants, by a trained physiotherapist. Primary outcomes: physical activity levels and sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the trainings will be analyzed from the collected data and intention-to-treat analysis. Between-groups differences will be measured by two-way ANOVA with repeated measures considering the baseline, post-training, and a 4-week follow-up.

The results of this trial will likely provide valuable new information about the effects of aerobic treadmill training in improving physical activity levels and sedentary behavior, through changes in cardiorespiratory fitness, for individuals following stroke.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The sample size has been calculated considering the physical activity levels measured by the Human Activity Profile (HAP). The effect size has been derived from the study of Teixeira-Salmela et al. 1999, who performed aerobic training in addition to lower limbs resistance training, and home exercises with subjects with chronic stroke. The experimental group (n=6) showed an increase on HAP on average of 20±6.1 points after the intervention, and the control group (n=7) had an average reduction of 1.86±0.19 points. Considering a significance level of 5% and a desired power of 80%, 9 participants per group was found, or 18 participants in total. Assuming an expected dropout rate of 20%, a target of 22 participants in total was set (11 participants per group).

Statistical analyses: A code will be given to each participant. Two independent examiners, blinded to the group allocation, will perform data entry, and verify missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. An independent examiner, blinded to the group allocation, will perform the statistical analysis by SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be performed for all outcome variables. Baseline variables will be compared between groups using independent Student's t-tests, to investigate differences among the groups regarding the clinical-demographical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors. The effects of the interventions will be analyzed from the collected data and the intention-to-treat analysis. Data from the last available assessment will be considered as the values of missed sessions. Between-groups differences will be measured with two-way ANOVA with repeated measures considering the baseline, post-training, and follow-up measures. Level of significance will be set at 0.05 and adjusted for multiple comparisons. Normality and equality of variance will also be analyzed to ensure correct use of parametric data. Study results will be spread regardless of the magnitude and direction of the effects.

Type d'étude

Interventionnel

Inscription (Réel)

22

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Brésil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brésil
        • Universidade Federal de Minas Gerais

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • ≥ 20years of age;
  • diagnosis of stroke (>6months);
  • sedentary or insufficiently active;
  • have a writing medical permission to participate in the training program.

Exclusion Criteria:

  • cognitive impairment (Mini-Mental Status Examination score: illiterate 13 points; elementary and middle school 18 points; and high-school 26 points; or inability to respond to verbal command);
  • inability to walk independently for at least 10 minutes, with or without walking devices;
  • pain or other disorders precluding their participation.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Aerobic treadmill training

Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.

Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill.
Autre: Aerobic treadmill training

Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.

Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill.
Comparateur factice: Control (overground walking)
Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program.
Autre: Control (overground walking)
Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the exercise, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Physical activity levels - multisensor monitor
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Physical activity levels will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Physical activity levels - Human Activity Profile
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Physical activity levels will be assessed by Human Activity Profile
At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in sedentary behavior - multisensor monitor
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Sedentary behavior will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
At baseline, 12 weeks post-intervention, and at 4-week follow-up

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Cardiorespiratory fitness - cardiopulmonary exercise test
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Cardiorespiratory fitness will be assessed by cardiopulmonary exercise test
At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Endurance - six minute walk test
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Endurance will be assessed by six minute walk test
At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Endurance - shuttle walk test
Délai: At baseline,12 weeks post-intervention, and at 4-week follow-up
Endurance will be assessed by shuttle walk test
At baseline,12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Depression - Patient Health Questionnaire (PHQ-2 and PHQ-9)
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Depression will be assessed by Patient Health Questionnaire (PHQ-2 and PHQ-9)
At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Mobility - gait speed
Délai: At baseline,12 weeks post-intervention, and at 4-week follow-up
Mobility will be assessed by gait speed
At baseline,12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Quality of life - Stroke specific quality of life
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Quality of life will be assessed by Stroke specific quality of life
At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Participation - Stroke impact scale
Délai: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Participation will be assessed by (Stroke impact scale)
At baseline, 12 weeks post-intervention, and at 4-week follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Federal University of Minas Gerais

Les enquêteurs

  • Chercheur principal: Christina Faria, Ph.D., Federal University of Minas Gerais

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 décembre 2017

Achèvement primaire (Réel)

15 octobre 2018

Achèvement de l'étude (Réel)

15 octobre 2018

Dates d'inscription aux études

Première soumission

6 juin 2016

Première soumission répondant aux critères de contrôle qualité

13 juin 2016

Première publication (Estimation)

14 juin 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2019

Dernière vérification

1 mai 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CAAE:51454115.6.0000.5149

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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